cyclosporine-a versus prednisolone for induction of remission in auto- immune hepatitis: interim analysis report of a randomized controlled trial

background corticosteroids are used to induce remission in auto-immune hepatitis. they are not universally effective; therefore, alternative treatments are needed. in this study cysclosporine-a has been compared with prednisolone as an alternative treatment in a randomized controlled trial. this paper is an interim analysis of an ongoing clinical trial. methods sixteen years and older consenting patients were enrolled. group-a received prednisolone and group-b cyclosporine-a according to a preset protocol and followed at regular intervals for 48 weeks. final assessment was done at week 48. primary outcome was response rate as defined below. “complete response „  was defined as achieving ast and alt in the normal range and absence of any clinical signs of deterioration, and partial response was defined as a decrease in ast and alt by less than half of their original values but not to within normal limit. non-responding ones at week eight were switched to the other arm. results thirty-nine patients were enrolled (24 group-a, 9 male). mean ast and alt at baseline were higher in group-b, but other variables were comparable. at week 12, 34.8% and 64.3% of group-a and b had achieved ast and alt in the normal range (less than 40 iu/l) respectively (p=0.081). corresponding figures at week 48 were 50.0% and 47.6% (p=0.62 & 0.48 respectively). at week 12, 86.9% and 85.7% of patients had ast and alt levels less than twice upper normal limit in groups-a and b respectively (p=0.54 & 0.42). corresponding figures at week 48 were 90.0% for both groups. there was one treatment failure in group-b which did not respond to prednisolone either. serious adverse events (death and liver transplantation) occurred in group-a only. serum creatinine did not change during the study period in either group. conclusion according to our data, cyclosporine-a is as effective as prednisolone for induction of remission in aih. adverse events and serious adverse events were more common with prednisolone.